Medical professionals and healthcare providers such as nurses and doctors routinely treat patients having various skin disorders including lacerations, abrasions, surgical incision, infected lesions, bacterial infections such as acne (i.e. Propionibacterium acnes), fungal infections such as Athlete's foot (i.e. fungal genus Trichophyton), conditions associated with hair loss including alopecia areata (patch baldness), alopecia totalis (complete baldness of the scalp) and alopecia universalis (body baldness) as well as ulcerations from systemic conditions such as diabetes, frostbite and burns. Variations in skin disorders and other patient indications dictate variations in desired medications for treatment, such as antibiotics, growth factors, enzymes, hormones, as well as protocols, such as delivery rates for medication and creating and maintaining an antiseptic environment.
The skin is a barrier and a first line of defense from external factors in the environment. It also functions to prevent excessive water loss, provide insulation, temperature regulation and sensation. When the skin is damaged or broken this protection is compromised subjecting the body to invasion by potential pathogens. Consequently, repairing or providing an environment in which the skin can repair itself is crucial for survival. Current treatment for skin lacerations and scrapes includes cleaning the site thoroughly with soap and water and keeping the wound clean and dry. The use of antibiotic ointments or hydrogen peroxide may also be used to reduce the possibility of infection. However, compliance with this protocol can be difficult to achieve for the length of time necessary to heal the wound. Consequently, when the area affected becomes red, swollen, and painful to the touch this generally indicates infection. Over a hundred thousand people die each year in hospitals from infections resulting from open wounds, several thousand loose limbs and still others are disfigured by scars left after the wound has healed.
A vast majority of bacteria are harmless or beneficial. However, there are a few that are pathogenic. One such bacterium, Propionibacterium acnes causes acne vulgaris, seborrhea (scaly red skin), comedone (blackheads and whiteheads) and pimples often resulting in scarring and in extreme cases disfigurement. It is estimated that nearly 85% of people between the ages of 12 to 24 develop acne. Young men are more likely to suffer the effects of acne for longer periods of time then young women because testosterone tends to make acne worse. In 2013, it was estimated that there were over 316 million people in the United States and approximately one third of those individuals were between the ages of 10 and 24. With close to 100 million suffering from acne in the United States (U.S.) alone the skin care industry for the past fifty or so years has been developing treatments but with limited success. Currently, most medications include one or more of the following chemicals: benzoyl peroxide, salicylic acid, glycolic acid, sulfur and azelaic acid. However, because most individual's skin is unique, it is difficult to find the appropriate formulation that will relieve or eliminate acne. Consequently, many individuals do not obtain proper treatment and are left to suffer with acne and often have scaring as a result. The need for effective treatment is evidenced by individuals spending over 78 billion dollars on skin care worldwide in 2010 with facial care capturing 64% of this market.
Athlete's foot also known as Tinea pedis is an inflammatory condition and represents the most common of all superficial fungal skin infections. Over 1 million individuals in the U.S. contract Athlete's foot each year. It is predominantly caused by a group of fungi called dermatophytes which includes Trichophyton rubrum, Trichophyton mentogrophytes var. interdigitale and Epidermophyton floccosum. For most patients, recurrent or chronic foot fungal infections are more of an inconvenience than a problem and treatment is rarely sought. This may explain the high prevalence of the disease. Cellulitis is a more serious consequence of an untreated fungal foot infection. Although treatable, it can be a limb-threatening disease for patients with comorbidities. Individuals with diabetes have an increased risk of developing this complication. The frequent outcome for this group is hospitalization and an increased length of stay when compared to their non-diabetic counterparts.
There are three main groups of topical agents for treating fungal skin infections, allylamines (i.e. terbinafine), imidazoles (i.e. clotrimazole, ketoconazole, sulconazole and miconazole) and morpholine derivatives (i.e. amorolfine). All have been demonstrated to be more effective than placebo. However, their speed of action varies making compliance difficult and often resulting in ineffective treatment.
Alopecia, or hair loss, affects approximately 35 million men and 21 million women in the U.S. Alopecia areata is a disorder that causes sudden hair loss on the scalp and other regions of the body. It affects more than 5 million Americans, 60% of them under the age of 20. It is not a health threat, but can be psychologically damaging, especially for children, to cope with baldness. Of men being treated for alopecia, approximately 85% are being treated with Minoxidil and approximately 15% are being treated with Finasteride. Minoxidil, more commonly known as Rogaine™ is a nonprescription medication approved for androgenetic alopecia and alopecia areata. In a liquid or foam, it is rubbed into the scalp twice a day. This is the most effective method to treat male-pattern and female-pattern hair loss. However, only 30-40% of patients experience hair growth and it is not effective for other causes of hair loss. Hair regrowth can take 8 to 12 months and treatment must be continued indefinitely because hair loss resumes if treatment is stopped. Finasteride (Propecia™) is used in male-pattern hair loss in a pill form taken on a daily basis. It is not indicated for women and is not recommended in pregnant women. Treatment is effective within six to eight months of treatment. Side effects include decreased libido, erectile dysfunction, ejaculatory dysfunction, gynecomastia, and myopathy. Treatment should be continued as long as positive results occur. Once treatment is stopped, hair loss resumes. In 2013, it is anticipated that men will spend over $225 million on medicinal therapies like Rogaine™. Unfortunately, the low percentage of success, potential side effects and lifetime treatment regimen make this option difficult for many individuals.
Another particular area of concern involves foot or limb wounds in diabetic patients. It is known that foot wounds in diabetic patients represent a significant public health problem throughout the world. Diabetes is a large and growing problem in the U.S. and worldwide, costing an estimated $45 billion dollars to the U.S. health care system. Patients afflicted with diabetes often have elevated glucose and lipid levels due to inconsistent use of insulin, which can result in a damaged circulatory system and high cholesterol levels. Often, these conditions are accompanied by deteriorating sensation in the nerves of the foot. As a result, diabetics experience a high number of non-healing foot ulcers.
It is estimated that each year up to three million leg ulcers occur in patients in the U.S., including venous stasis ulcers, diabetic ulcers, ischemic leg ulcers, and pressure ulcers. The national cost of chronic wounds is estimated at $6 billion. Diabetic ulcers often progress to infections, osteomyelitis and gangrene, which often results in toe amputations, leg amputations, and in some cases death. In 1995, approximately 70,000 such amputations were performed at a cost of $23,000 per toe and $40,000 per limb. Many of these patients progress to multiple toe amputations and contralateral limb amputations. In addition, these patients are at an increased risk of heart disease and kidney failure from arteriosclerosis which attacks the entire circulatory system.
The conventional methods of treatment for non-healing diabetic ulcers include wound dressings of various types, antibiotics, wound healing growth factors, skin grafting including tissue engineered grafts, use of wheelchairs and crutches to remove mechanical pressure, and finally amputation. In the case of ischemic ulcers, surgical revascularization procedures via autografts and allografts and surgical laser revascularization have been applied with short term success, but with disappointing long term success due to reclogging of the grafts. In the treatment of patients with venous stasis ulcers and severe venous disease, antibiotics and thrombolytic anticoagulant and anti-aggregation drugs are often indicated. The lack of success of conventional methods is demonstrated by the failure to heal these wounds and their frequent recurrence. Accordingly, the medical community has a critical need for a low cost, portable, non-invasive method of treating diabetic, venous, ischemic and pressure ulcers to reduce mortality and morbidity and reduce the excessive costs to the health care system.
Most problematic of all is that treatment of diabetic foot ulcers has been focused on amputation and not on limb salvage primarily because the wounds have not been properly treated. Improper treatment can be attributed to lack of an easy and inexpensive treatment system and severe inconvenience to the patient in using current methods. There is a need to prevent amputation by healing such wounds, particularly at an early stage.
Furthermore, amputation for conditions such as foot ulcers and frostbite becomes less avoidable the longer the condition is either left untreated or is unsuccessfully treated. Therefore, it is crucial to apply an effective treatment regimen as soon as possible. Unfortunately, foot wounds in patients with, for example, diabetes develop because of a process called neuropathy. Diabetes causes loss of sensation such that skin injury and complete breakdown (ulcer) can develop with no or minimal pain. These wounds tend not to heal because of ongoing mechanical trauma not felt at all by the patient as painful. Therefore, by the time the patient discovers the wound, the wound has often progressed so that the patient's treatment options have become severely limited.
In many cases, such wounds can only be healed by protecting them from mechanical trauma. Small plantar ulcers in diabetic patients are usually seen by primary care practitioners and endocrinologists. The present method for healing plantar ulcers is a total contact cast for the foot, which provides complete mechanical protection. This method is not ideally suited for either of these practice settings, because it requires skilled and specialized care in application, along with frequent follow up. Most patients perceive the cast to be an inconvenience at the early stages of such a wound, while perceiving that such a wound is not a serious matter. The alternative to the cast is to have the patient use a wheelchair, crutches, or a walker, which can provide mechanical protection only with complete patient compliance. This alternative rarely proves to be effective in healing wounds within a reasonable time period.
Burn injuries affected approximately 450,000 individuals in 2013 according to The American Burn Association (www.ameriburn.org). Of these, approximately 40,000 resulted in hospitalization including 30,000 at hospital burn centers. Men (69%) were affected almost twice as much as women (31%). There are three burn classifications, first-degree burn, second-degree burn and third-degree burn. First degree burns are the least serious only involving the outer layer of skin. The skin is usually red, often swollen and painful. A second degree burn occurs when the second layer of skin (dermis) also is burned. When this occurs blisters develop, the skin has an intensely red splotchy appearance, swollen and very painful. In most circumstances, second degree burns no larger than three inches in diameter may be treated as a minor burn. Larger areas require immediate medical assistance. Treatment for minor burns including first-degree burns and limited area second-degree burns include: cooling the burn with cool running water for 10 or 15 minutes or until the pain subsides. This will reduce swelling by conducting heat away from the skin. Cover the burn with a sterile gauze bandage wrapped loosely about the affected area to avoid putting pressure on burned skin. Bandaging keeps air off the burn, reduces pain and protects blistered skin. Taking an over the counter pain reliever such as aspirin, ibuprofen, naproxen or acetaminophen can ease the discomfort. Minor burns usually heal without further treatment but often heal with significant pigment changes. However, continued redness, pain, swelling or oozing often indicates infection that can result in further damage, discoloration and disfigurement of the affected area.
Third degree burns are the most serious involving all layers of the skin and often include fat, muscle and sometimes bone. Hospitalization is the best treatment for third degree burns. Discoloration and disfigurement often occur with third degree burns.
Consequently, there is a need in the wound treatment industry is a method for treating abrasions and lacerations of the skin, bacterial and fungal skin infections, hair loss, skin ulcers, burns and other wounds that does not require extended physician time and that is effective even at later stages of the medical condition. Also, what is needed is a treatment that allows patients to be able to continue their active lives without the need to wear casts, or be confined to wheelchairs and/or crutches.